# 510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-05-06
- Length: 43m
- Episode: 145
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie
- Listen: https://podcast.greenlight.guru/episode/510k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companies

## Summary

Mike Drues, president of Vascular Sciences, joins host Jon Speer to explain the 510(k) regulatory pathway for Class II medical devices, emphasizing the requirements for substantial equivalence and device classification. They discuss the three types of 510(k) submissions—Traditional, Special, and Abbreviated—and advise on timing, noting that design freeze and verification/validation testing must be complete before submission, with promissory notes being rarely accepted today. The conversation highlights the importance of clinical evidence based on the totality of evidence rather than pathway type, and details the Refuse to Accept (RTA) administrative review process, urging companies to use RTA checklists to avoid common paperwork errors.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=0) Introduction: Mike Drues and Vascular Sciences
- [2:18](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=138) 510(k) Criteria: Class II and Substantial Equivalence
- [6:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=373) Types of 510(k): Traditional, Special, and Abbreviated
- [13:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=787) Submission Timing and Promissory Notes
- [25:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=1553) Manufacturing Requirements and Design Controls
- [27:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=1625) Clinical Evidence and Totality of Evidence
- [35:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie#t=2133) RTA Administrative Review and Checklists

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- Vascular Sciences (company)
- FDA (other)
- CDRH (other)
- EASTR (other)

## Related episodes from other shows

- [106 - FOIA, FDA Modernizing 510(k) Program, De Novo Submissions, and more databases with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-10-24-106-foia-fda-modernizing-510-k-program-de-novo-submissions-and-more-databases-wi) (Let's Combinate)
- [077 - 8 Databases and How To Use Them with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-22-077-8-databases-and-how-to-use-them-with-michelle-lott) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!](https://hardwarepodcasts.com/podcast/lets-combinate/2024-10-30-160-drug-tech-transfer-vs-device-design-transfer-explained) (Let's Combinate)
- [074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-05-06-510-k-tips-and-answers-to-frequently-asked-questions-for-medical-device-companie. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.